Palivizumab Injection

WHY is this medicine prescribed?

Palivizumab injection is used to help prevent respiratory syncytial virus (RSV; common virus that can cause serious lung infections) in children less than 24 months old who are at high risk for getting RSV. Children at high risk for RSV include those who were born prematurely or have certain heart or lung diseases. Palivizumab injection is not used to treat the symptoms of RSV disease once a child already has it. Palivizumab injection is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the spread of the virus in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Palivizumab injection comes as a liquid to be injected into the muscles of the thigh by a doctor or nurse. The first dose of palivizumab injection is usually given before the beginning of RSV season, followed by a dose every 28 to 30 days throughout RSV season. RSV season usually starts in the fall and continues through spring (November through April ) in most parts of the United States but may be different where you live. Talk to your doctor about how many shots your child will need and when they will be given.

If your child has surgery for certain types of heart disease, your healthcare provider may need to give your child an additional dose of palivizumab injection soon after surgery, even if it has been less than 1 month from the last dose.

Your child may still get severe RSV disease after receiving palivizumab injection. Talk to your child's healthcare provider about the symptoms of RSV disease. If your child has an RSV infection, he should still continue to receive his scheduled palivizumab injections to help prevent serious disease from new RSV infections.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving palivizumab injection,

• tell your child's doctor and pharmacist if your child is allergic to palivizumab, any other medications, or any of the ingredients in palivizumab injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products your child is taking or plans to take. Be sure to mention anticoagulants ('blood thinners'). Your doctor may need to change the doses of your child's medications or monitor him carefully for side effects.

• tell your doctor if your child has or has ever had a low platelet count or any type of bleeding disorder.

What SPECIAL DIETARY instructions should I follow?

Unless your child's doctor tells you otherwise, continue his normal diet.

What should I do IF I FORGET to take a dose?

If your child misses an appointment to receive palivizumab injection, call his doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Palivizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fever
• rash
• redness, swelling, warmth, or pain in the area where the injection was given

Some side effects can be serious. If your child experiences any of these symptoms, call his doctor immediately or get emergency medical treatment:

• severe rash, hives, or itching skin
• unusual bruising
• groups of tiny red spots on the skin
• swelling of the lips, tongue, or face
• difficulty swallowing
• difficult, rapid, or irregular breathing
• bluish-tinged skin, lips, or fingernails
• muscle weakness or floppiness
• loss of consciousness

Palivizumab injection may cause other side effects. Call your doctor if your child has any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that your child is receiving palivizumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.